First episode psychosis and treatment resistant schizophrenia Mental and Behavioural Disorders
Conditions
Interventions
Patients with a diagnosis of First episode Psychosis (FEP) will be recruited. The participants will be assessed at the baseline and follow up in 1, 3,6, and 12-month period with pre identified tools.
Sponsors
Keele University
Eligibility
Sex/Gender
All
Age
16 Years to 40 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 03/08/2026: 1. Patients aged 16-40 years 2. Residing within the study districts 3. Diagnosed with First-ever psychotic episode who have not received antipsychotic medication previously, or if they already have used antipsychotic medications, it was for no longer than six weeks Previous key inclusion criteria: 1. Patients aged 18-35 years 2. Residing within the study districts 3. Diagnosed with First-ever psychotic episode who have not received antipsychotic medication previously, or if they already have used antipsychotic medications, it was for no longer than six weeks
Exclusion criteria
Exclusion criteria: 1. Those with an overt learning disability 2. Those with severe substance abuse (except nicotine dependence) 3. Those with organic illness associated with psychotic symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Disengagement from service is measured using clinic records and care coordinator notes at 1, 3, 6, and 12 months 2. Remission is measured using PANSS (score =3) or YMRS (score =12) at 1, 3, 6, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in occupational and social functioning is measured using WHODAS 2.0 at 1, 3, 6, and 12 months 2. Psychopathology symptom severity is measured using PANSS, YMRS, and HDRS at 1, 3, 6, and 12 months 3. Family burden is measured using the Family Burden Scale at 3 and 12 months 4. Perceived stigma is measured using the Modified Internalized Stigma of Mental Illness tool (ISMI) at 12 months 5. Blood pressure is measured using clinic records at 1, 3, 6, and 12 months 6. BMI is measured using clinic records at 1, 3, 6, and 12 months 7. Cardiovascular disease risk is measured using WHO-STEPS at 12 months 8. Appropriateness is measured using the Intervention Appropriateness Measure tool (IAM) at 12 months 9. Feasibility is measured using the Feasibility Intervention Measure at 12 months 10. Acceptability is measured using the Applied Mental Health Research Group tool at 12 months 11. Fidelity of CBT delivery is measured using the Revised Cognitive Therapy Scale (CTS-R) at 12 months 12. Implementation cost is measured using administrative data logs collected over the one-year period | — |
Countries
Pakistan, Sri Lanka
Contacts
Public ContactNishani Fonseka
Outcome results
None listed